CU IRB: Assent October 2016
IMPORTANT: ALL SECTIONS ARE REQUIRED UNLESS OTHERWISE NOTED. BEFORE FINALIZING & UPLOADING THIS DOCUMENT, REMOVE: THIS SECTION, ALL [RED INSTRUCTIONAL TEXT] AND BLUE GUIDELINES.
Notes:
The readability of the assent has to be age appropriate which means it could be at a 1st or 3rd or 6th grade reading level or anything in between depending on the age or circumstances of the minor. For example, detained adolescent youths typically have a reading level of 3rd grade. Do not assume that literacy and age are correlated.
Young people are often confused by the “we” in the consent template. Unless there are a number of people involved in obtaining assent, use the pronoun ‘I,’ not ‘we.’
CHAPMAN UNIVERSITY
ASSENT TO PARTICIPATE IN RESEARCH
[Title of Study]
[If the study title is overly-technical, consider adding a lay title here]
Participating in this study is totally voluntary. Please read about the study below. Feel free to ask questions about anything that you do not understand before deciding if you want to be in the study. A researcher listed below will be around to answer your questions.
PRINCIPAL INVESTIGATOR
PI Name and Title
College/School/Dept
PI Phone
PI Email
24 Hour Telephone number [Required for medical studies and clinical investigations]
STUDY SPONSOR(S):
STUDY LOCATION(S):
Why am I being asked to take part in this research study?
A research study is usually done to find a better way to treat people or to understand how things work. You are being asked to take part in this research study because you are a teenager who is 14 or older.
What should I know about a research study?
You do not have to be in this study if you do not want to do so. It is up to you if you want to participate. You can choose not to take part now and change your mind later if you want. Your decision will not be held against you. You can ask all the questions you want before you decide.
Why is this research being done?
In this study, I want to find out more about [complete this sentence]. Example: …what teens think about when they are planning to start dating or when they have decided to ask someone out.
How long will the research last?
I expect that you will be in this research study [complete this sentence].
What happens if I say “Yes, I want to be in this research”?
If it is okay with you and you agree to join this study, you will be asked to [complete this section using a bulleted list to outline the study procedures that will occur. Use terminology that children will understand].
Is there any way being in this study could be bad for me?
You may feel uncomfortable with some of the…..[complete this with a description of all risks and discomforts associated with the study procedures, using terminology that children will understand]
Example:…..questions that I will ask. You can skip any questions you do not want to answer and you can stop at any time.
What happens to the information collected for the research?
I will try to limit other people from seeing your personal information. Some people who have a need to see your information will be allowed. I cannot promise complete secrecy.
Will you get better if you are in the study?
[Describe any possible benefits to the participant, to others or society, using terminology that children will understand]
What else do I need to know?
[Include additional information here]
Example: If you agree to take part in this research study, I will give you a $10 gift card to a local vendor.
Who can I talk to?
[List people the child can contact if he/she has any questions or problems related to the study, for example:]
If you have any questions about the study or any problems to do with the study you can contact the Principal Investigator (name). You can call him/her at (phone number). You can also call (name) at (phone number).
If you have questions about the study but want to talk to someone else who is not a part of the study, you can call the Chapman University Institutional Review Board (IRB) at (714)-628-2833.
Do you have to be in the study?
You do not have to be in the study. No one will be mad at you if you don’t want to do this. If you don’t want to be in this study, you just have to tell the researchers. If you want to be in this study, you just have to tell them. You can say yes now and change your mind later. It is up to you to decide.
AUDIO RECORDING: / <If not applicable, delete this entire section>Someone explained to me that my voice will be recorded for this research. I allow my voice to be recorded during this research study, and for others doing the research to listen to my recorded voice.
_____Yes, I agree to allow the research team to audio record my voice.
_____No, I do not wish to have my interview audio recorded.
Signature of Participant / Date
VIDEO RECORDING: / <If not applicable, delete this entire section>
Someone explained to me that I will be video recorded for this research. I allow myself to be recorded during this research study, and for others doing the research to view this video.
_____Yes, I agree to allow the research team to video record (study procedures, my interview, etc.)
_____No, I do not wish to have my interview or procedure sessions(s) video recorded.
Signature of Participant / Date
Signature Block for Child Assent
______
Signature of child Date
______
Printed name of child
______
Printed name of person obtaining assent Date
______
Signature of person obtaining assent
A witness signature is required on this assent form only if: (Researchers: check which one applies)
The subject has decision-making capacity, but cannot read, write, talk or is blind.
The IRB specifically mandated a witness signature for this study.
The witness must be impartial (i.e. not a member of the subject’s family, not a member of the study team).
For the witness:
I confirm that the information in this assent form was accurately explained to and understood by the subject or legally authorized representative and that informed assent was given freely.
______
Witness Signature Date
(If no witness signature is required, this witness signature section of the assent form may be left blank).
______
Printed Name of Witness
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